Lead Regulatory Health Project Manager
This Direct-Hire position is in the Food and Drug Administration and is located in the Center for Biologics Evaluation and Research (CBER), in Silver Spring, MD.
Responsibilities
- Serves as expert on regulated scientific project review teams.
- Coordinates regulated product application review teams.
- Serves as contact for all regulatory issues related to the initiatives, responsible for communicating directly with external counterparts to resolve issues, facilitate technical information gathering for reviewers and explain regulatory requirements.
- Prepares reports, briefing materials and scientific policies.